Fenofibrate
- Generic Name
- Fenofibrate
- Brand Names
- Antara, Cholib, Fenoglide, Fenomax, Lipidil Supra, Lipofen, Tricor, Triglide
- Drug Type
- Small Molecule
- Chemical Formula
- C20H21ClO4
- CAS Number
- 49562-28-9
- Unique Ingredient Identifier
- U202363UOS
- Background
Fenofibrate is a fibric acid derivative like clofibrate and gemfibrozil. Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia.
Fenofibrate was granted FDA approval on 31 December 1993.
- Indication
Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase HDL-C adults with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate is also indicated to treat adults with severe hypertriglyceridemia.
- Associated Conditions
- Mixed Dyslipidemias, Primary Hypercholesterolemia, Severe Hypertriglyceridemia (sHTG), Severe Fredrickson Type IV Hypertriglyceridemia, Severe Fredrickson Type V Hypertriglyceridemia
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
- Conditions
- Hypercholesterolaemia
- Interventions
- First Posted Date
- 2018-04-27
- Last Posted Date
- 2023-05-06
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 153
- Registration Number
- NCT03510884
- Locations
- 🇪🇸
Investigational Site Number :7240003, Pamplona, Navarra, Spain
🇵🇱Investigational Site Number :6160002, Gdansk, Pomorskie, Poland
🇲🇽Investigational Site Number :4840007, Oaxaca, Mexico
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
- Conditions
- Hypercholesterolemia
- Interventions
- First Posted Date
- 2018-04-27
- Last Posted Date
- 2020-12-29
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 18
- Registration Number
- NCT03510715
- Locations
- 🇩🇰
Investigational Site Number 2080001, Viborg, Denmark
🇪🇸Investigational Site Number 7240001, A Coruna, Spain
🇸🇮Investigational Site Number 7050001, Ljubljana, Slovenia
Lowering Events in Non-proliferative Retinopathy in Scotland
- Conditions
- Diabetic Retinopathy
- Interventions
- Drug: Placebo Oral Tablet
- First Posted Date
- 2018-02-20
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- University of Oxford
- Target Recruit Count
- 1151
- Registration Number
- NCT03439345
- Locations
- 🇬🇧
NHS Lothian, Edinburgh, United Kingdom
🇬🇧NHS Grampian, Aberdeen, United Kingdom
🇬🇧NHS Dumfries and Galloway, Dumfries, United Kingdom
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Mild or Moderate Renal Impairment
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- First Posted Date
- 2017-01-05
- Last Posted Date
- 2022-10-28
- Lead Sponsor
- Kowa Research Institute, Inc.
- Target Recruit Count
- 471
- Registration Number
- NCT03011450
- Locations
- 🇺🇸
South Florida Research Solutions LLC., Pembroke Pines, Florida, United States
🇺🇸Boyett Health Services Inc, Hamilton, Alabama, United States
🇺🇸Longwood Research - Saadat Ansari, MD, LLC, Huntsville, Alabama, United States
Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function
- Conditions
- Severe Hypertriglyceridemia
- Interventions
- First Posted Date
- 2016-12-23
- Last Posted Date
- 2022-11-30
- Lead Sponsor
- Kowa Research Institute, Inc.
- Target Recruit Count
- 551
- Registration Number
- NCT03001817
- Locations
- 🇺🇸
Maryland Cardiovascular Specialist, Baltimore, Maryland, United States
🇺🇸Protenium Clinical Research, LLC - Dallas, Dallas, Texas, United States
🇺🇸Centex Studies, Inc., Houston, Texas, United States
Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
- Conditions
- HypercholesterolemiaAcute Coronary Syndrome
- Interventions
- First Posted Date
- 2016-12-07
- Last Posted Date
- 2019-09-09
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 206
- Registration Number
- NCT02984982
- Locations
- 🇯🇵
Investigational Site Number 392008, Gifu-shi, Japan
🇯🇵Investigational Site Number 392022, Chiyoda-ku, Japan
🇯🇵Investigational Site Number 392039, Hiroshima-shi, Japan
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
- First Posted Date
- 2016-11-17
- Last Posted Date
- 2021-09-17
- Lead Sponsor
- Beijing 302 Hospital
- Registration Number
- NCT02965911
- Locations
- 🇨🇳
Beijing 302 hospital, Beijing, China
Study to Evaluate the Pharmacokinetics of Firsocostat or Fenofibrate in Adults With Normal and Impaired Hepatic Function
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Interventions
- First Posted Date
- 2016-09-07
- Last Posted Date
- 2020-12-17
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 74
- Registration Number
- NCT02891408
An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
- Conditions
- Hypercholesterolaemia
- Interventions
- First Posted Date
- 2016-09-07
- Last Posted Date
- 2019-09-06
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 42
- Registration Number
- NCT02890992
- Locations
- 🇨🇿
Investigational Site Number 2030002, Zlin, Czechia
🇺🇸Investigational Site Number 8400005, Charlotte, North Carolina, United States
🇺🇸Investigational Site Number 8400001, Cincinnati, Ohio, United States
Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis
- Conditions
- Fenofibrate/Simvastatin Comparison
- Interventions
- First Posted Date
- 2016-09-01
- Last Posted Date
- 2016-09-05
- Lead Sponsor
- Cairo University
- Target Recruit Count
- 60
- Registration Number
- NCT02886299
Drug Development Updates
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